Evaluating the Acceptability, Feasibility and Usability of Various Conversational Data Collection Software

NCT07336537 | Recruiting DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being conducted to evaluate digital software tools that collect health information through conversations. The study will test how acceptable, feasible, and usable these conversational software programs are for patients with chronic pain. Purpose of the Study: The goal is to understand whether digital conversational tools can effectively gather biopsychosocial information (biological, psychological, and social factors related to health) from patients experiencing chronic pain. Biopsychosocial information includes details about your physical symptoms, emotional well-being, social circumstances, and how these factors interact to affect your health. These digital tools are designed to have conversation-like interactions with patients to collect this comprehensive health data in a more natural and engaging way. What Participation Involves: If you join this study, you will interact with digital conversational software that will ask you questions about your health, pain experience, and related factors. The software is designed to communicate with you in a conversational manner, similar to talking with a healthcare provider, to gather information about your condition. You will be asked about various aspects of your chronic pain experience, including how it affects your daily life, your emotional state, and your social interactions. Who Can Participate: This study is looking for participants who have chronic pain conditions. Medical providers who treat patients with chronic pain are encouraged to refer eligible patients to this study. Healthcare providers interested in referring patients or learning more about the study can contact the study sponsor, AugMend Health Inc. Why This Research Matters: Chronic pain affects millions of people and understanding the full scope of how it impacts patients requires collecting detailed information about physical, psychological, and social factors. Traditional methods of collecting this information can be time-consuming and may not capture the complete picture. Digital conversational tools offer a potential new approach to gathering comprehensive health information in a more efficient and patient-friendly manner. This research will evaluate whether patients find these tools acceptable to use, whether they work practically in real-world clinical settings, and whether they are user-friendly and accessible for people with chronic pain. Study Location: The study is being conducted at AugMend Health in Cambridge, Massachusetts. Study Sponsor: This study is sponsored by AugMend Health Inc. Healthcare providers or potential participants who would like more information about the study or wish to make a referral can contact AugMend Health Inc. Participation in this study is voluntary, and you can choose to stop participating at any time without affecting your regular medical care.

Conditions

Chronic Pain; Mental Health Disorders; Behavioral Health Challenges; Ecological Momentary Assessment Best Practices

Keywords

Chronic Pain; Behavioral Health; Mental Health; Technology; Assessment; Data Collection; Biopsychosocial; Digital Health

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Acceptability will be measured using the Acceptability, Feasibility and Usability Survey (AFUS) - Acceptability Subscale, a researcher-developed instrument. This subscale includes items from Part 1 (Core Assessment Experience), Part 2 (culture), Part 3 (Future Use \& Preference), Part 4 (Privacy \& Trust), and Part 5 (Medical Disclosure Comfort). Items are rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). Subscale scores will be calculated as the mean of all acceptability items. Higher scores indicate greater acceptability. Subscale breakdown will be accessible in supplemental figures of publications.

  Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)

• Usability

  Usability will be measured using the Acceptability, Feasibility and Usability Survey (AFUS) - Usability Subscale (Part 6), a researcher-developed instrument adapted from established usability frameworks. The subscale consists of 10 items rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). Negatively-worded items are reverse-scored. The total score is calculated as the mean of all items. Higher scores indicate better usability.

  Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)

• Technical Feasibility

  Technical feasibility will be measured by the proportion of data collection sessions completed without significant technical failures. A significant technical failure is defined as any system error, software malfunction, connectivity interruption, hardware issue, or other technical problem that results in early termination of the session. Technical success rate will be calculated as the number of sessions without significant technical failures divided by total sessions attempted, expressed as a percentage. Higher percentages indicate greater technical feasibility.

  Assessed throughout study participation (typically within 1-2 weeks of enrollment)

• Implementation Feasibility

  Implementation feasibility will be measured using the Acceptability, Feasibility and Usability Survey (AFUS) - Future Use \& Preference Subscale (Part 3). Items assess participant willingness to use the data collection method again, likelihood of recommending it to others, and trust in the method for ongoing health evaluation. Items are rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). The subscale score is calculated as the mean of all items. Higher scores indicate greater implementation feasibility.

  Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)

• Data Collection Feasibility

  Feasibility of comprehensive data collection will be measured by the proportion of biopsychosocial domains for which data was successfully collected across all sessions. Domain coverage will be calculated as the number of domains with complete data divided by total possible domains, expressed as a percentage. Domains include biological (pain characteristics, sleep, physical function, nutrition), psychological (mood, cognition, coping, trauma, pain catastrophizing), and social (relationships, support, work, identity). Higher percentages indicate more comprehensive data collection.

  Assessed at completion of all data collection procedures (typically within 1-2 weeks of enrollment)

Secondary Outcomes (5)

• Participant Experience & Satisfaction

  Assessed immediately after completion of data collection procedures (typically within 1-2 weeks of enrollment)

• Patient Engagement - Session Duration

  Measured during each data collection session (typically within 1-2 weeks of enrollment)

• Patient Engagement - Response Elaboration

  Measured during each data collection session (typically within 1-2 weeks of enrollment)

• Perceived Therapeutic Alliance

  Assessed immediately after completion of conversational data collection (typically within 1-2 weeks of enrollment)

• Immersion and Comfort

  Assessed immediately after completion of immersive data collection (typically within 1-2 weeks of enrollment)

Other Outcomes (8)

• Correlation Between Physiological Measures and Engagement

  Assessed during in-person data collection sessions (typically within 1-2 weeks of enrollment)

• Correlation Between Physiological Measures and Self-Reported Affect

  Assessed during in-person study sessions (typically within 1-2 weeks of enrollment)

• Emotive & Linguistic Analysis

  Assessed at completion of the data collection (typically within 1-2 weeks of enrollment)

Study Arms (2)

Experimental Digital Biopsychosocial Data Collection Software

EXPERIMENTAL

Participants in this arm will use digital software to provide biopsychosocial information about their chronic pain condition. The software will collect data about participants' pain experiences, physical functioning, emotional well-being, social circumstances, and other health-related factors. Participants may complete study procedures at home or at the MIT.nano Immersion Lab depending on the technical requirements and study protocol. They will interact with the digital platform to provide comprehensive health information and will be asked to provide feedback on their experience with the data collection method. This arm evaluates the acceptability (whether patients find the tool appropriate and are willing to use it), feasibility (whether it can be practically implemented in real-world settings), and usability (how easy and intuitive the tool is for patients) of the digital data collection approach.

Other: Digital Biopsychosocial Conversational Data Collection Software

Control Standard Data Collection Method

ACTIVE COMPARATOR

Participants in this arm will use a standard method to provide biopsychosocial information about their chronic pain condition. They will provide data about their pain experiences, physical functioning, emotional well-being, social circumstances, and other health-related factors using conventional data collection approaches. Participants may complete study procedures at home or at designated study locations depending on the study protocol. They will provide comprehensive health information through the assigned data collection method and will be asked to provide feedback on their experience. This arm serves as a comparison group to evaluate the acceptability (whether patients find the method appropriate and are willing to use it), feasibility (whether it can be practically implemented in real-world settings), and usability (how easy and intuitive the method is for patients) of standard data collection approaches.

Other: Standard Digital Questionnaire Data Collection

Interventions

Digital Biopsychosocial Conversational Data Collection Software OTHER

This intervention involves participants interacting with digital conversational software that uses artificial intelligence and natural language processing to collect biopsychosocial health information. The software engages participants in dialogue-based interactions, asking questions about their chronic pain experience, physical functioning, emotional well-being, and social circumstances. The conversational interface adapts to participant responses, can ask follow-up questions for clarification, and creates an interactive experience that mimics clinical interviews. Some implementations may utilize virtual reality (VR) environments to create immersive data collection experiences at the MIT.nano Immersion Lab. Participants interact with the software either at home using provided devices or at the MIT.nano Immersion Lab. The AI-driven platform standardizes data collection while maintaining conversational flexibility, collecting comprehensive biopsychosocial data through natural language

Also known as: AugMend Conversational AI Platform, Virtual Reality Biopsychosocial Data Collection Tool, CADS VR, Web CADS

Experimental Digital Biopsychosocial Data Collection Software

Standard Digital Questionnaire Data Collection OTHER

This intervention involves participants completing standard digital questionnaires or surveys to provide biopsychosocial health information. Participants respond to predetermined, fixed-format questions about their chronic pain experience, physical functioning, emotional well-being, and social circumstances. The data collection uses conventional electronic forms or surveys with static question sets that do not adapt based on participant responses. Questions are presented in a standard sequence without conversational elements or follow-up prompts. This represents traditional electronic data collection methods commonly used in clinical and research settings. Participants complete the questionnaires either at home using their own devices or provided equipment, or at designated study locations. This method provides a comparison baseline against which to evaluate newer digital data collection approaches, representing current standard practice for gathering patient-reported health informat

Also known as: Traditional Electronic Survey Method, Static Standardized Digital Surveys

Control Standard Data Collection Method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of chronic pain (pain lasting 3 months or longer)
• Able to read and understand English
• Able to provide informed consent
• Willing and able to complete study procedures either at home or at the MIT.nano Immersion Lab
• Access to necessary technology for home-based participation (if assigned to home-based group), or ability to travel to the MIT.nano Immersion Lab (if assigned to laboratory-based group)
• Cognitively able to interact with digital data collection software and provide feedback

You may not qualify if:

• Under 18 years of age
• Unable to provide informed consent
• Non-English speaking
• Acute pain only (pain lasting less than 3 months)
• Cognitive impairment that would prevent meaningful interaction with data collection software or ability to provide valid feedback
• Unable or unwilling to complete study procedures in assigned setting (home or laboratory)
• Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with the participant's ability to complete study procedures

Sponsors & Collaborators

• AugMend Health Inc.: lead

Study Sites (1)

AugMend Health at MIT.nano Immersion Lab

Cambridge, Massachusetts, 02139, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Mark Ruchman, MD

  AugMend Health

  PRINCIPAL INVESTIGATOR

• Alexandra Therond, MA

  AugMend Health

  STUDY CHAIR

Central Study Contacts

Mark Ruchman, MD

CONTACT

+1 (203) 598-9557; mruchman@augmend.health

Study Coordinator

CONTACT

amurnane@augmend.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study uses a parallel group design to compare different digital biopsychosocial data collection methods in patients with chronic pain. Participants will be assigned to one of multiple study groups, each using a different approach to collect health information. Participants will remain in their assigned group throughout the study duration. The parallel design allows for direct comparison of acceptability, feasibility, and usability outcomes across different data collection approaches. Each group will complete the same types of assessments and provide feedback on their experience, enabling researchers to evaluate which methods work best for patients with chronic pain. Participants may complete study procedures either at home or at the MIT.nano Immersion Lab, depending on their assigned group and the technical requirements of their data collection method. All groups will provide comparable biopsychosocial information, but the format and platform through which this information is coll

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: January 13, 2026
• Study Start: October 3, 2025
• Primary Completion: February 11, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)